Cleared Traditional

K810428 - VICRYL

K810428 is the FDA 510(k) clearance for VICRYL by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K810428 · Ethicon, Inc. · General & Plastic Surgery device
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Mar 1981
Decision
23d
Days
Class 2
Risk

K810428 is an FDA 510(k) clearance for the VICRYL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K810428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 13, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K810428.
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655 · United States Surgical, A Division of Tyco Healthc · Dec 1990
STERILIZATION OF GORE-TEX SOFT TISSU
K833764 · W.L. Gore & Associates, Inc. · Jan 1984
GORE-TEX TISSUE REINFORCEMENT PATCH
K820193 · W.L. Gore & Associates, Inc. · Mar 1982
USHER'S MARLEX TUBULAR MESH
K792281 · Davol, Inc. · Nov 1979